80 FR 16413 - Medicare Program; Updates to the List of Durable Medical Equipment (DME) Specified Covered Items That Require a Face-to-Face Encounter and a Written Order Prior to Delivery

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 59 (March 27, 2015)

Page Range		16413-16414
FR Document		2015-07108

This notice updates the Healthcare Common Procedure Coding System (HCPCS) codes on the Durable Medical Equipment (DME) List of Specified Covered Items that require a face-to-face encounter and a written order prior to delivery.

Federal Register, Volume 80 Issue 59 (Friday, March 27, 2015)

[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16413-16414]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07108]



[[Page 16413]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6062-N]


Medicare Program; Updates to the List of Durable Medical 
Equipment (DME) Specified Covered Items That Require a Face-to-Face 
Encounter and a Written Order Prior to Delivery

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice updates the Healthcare Common Procedure Coding 
System (HCPCS) codes on the Durable Medical Equipment (DME) List of 
Specified Covered Items that require a face-to-face encounter and a 
written order prior to delivery.

DATES: March 27, 2015.

FOR FURTHER INFORMATION CONTACT: Charlene Harven (410) 786-8228.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 1832, 1834, and 1861 of the Act establish that the 
provision of durable medical equipment, prosthetic, orthotics, and 
supplies (DMEPOS) is a covered benefit under Part B of the Medicare 
program.
    Section 1834(a)(11)(B)(i) of the Act, as redesignated by the 
Affordable Care Act, authorizes us to require, for Specified Covered 
Items, that payment may only be made under section 1834(a) of the Act 
if a physician has communicated to the supplier a written order for the 
item before delivery of the item. Section 1834(b)(3) of the Act states 
that section 1834(a)(11) of the Act applies to prosthetic devices, 
orthotics, and prosthetics in the same manner as it applies to items of 
DME. Section 1834(a)(11)(B)(ii) of the Act requires a physician to 
document that a physician, physician assistant (PA), nurse practitioner 
(NP) or clinical nurse specialist (CNS) has had a face-to-face 
encounter examination with a beneficiary in the 6 months prior to the 
written order for certain items of durable medical equipment (DME) or 
during a different reasonable timeframe determined by the Secretary.
    In the Calendar Year (CY) 2013 Physician Fee Schedule (PFS) final 
rule with comment period, which appeared in the November 16, 2012 
Federal Register (77 FR 69147), we implemented section 1834(a)(11)(B) 
of the Act by making revisions to 42 CFR 410.38(g). Among other things, 
we established a list of Specified Covered Items that require a written 
order prior to delivery and a face-to-face encounter during the 6 
months prior to the written order. (See 42 CFR 410.38(g)(2).) The list 
of Specified Covered Items contains items that meet at least one of the 
following three criteria:
     Any item described by a Healthcare Common Procedure Coding 
System (HCPCS) code for the following types of durable medical 
equipment:
    ++ Transcutaneous electrical nerve stimulation (TENS) unit.
    ++ Rollabout chair.
    ++ Oxygen and respiratory equipment.
    ++ Hospital beds and accessories.
    ++ Traction-cervical.
     Any item of durable medical equipment that appears on the 
DMEPOS Fee Schedule with a price ceiling at or greater than $1,000.
     Any other item of durable medical equipment that CMS adds 
to the list of Specified Covered Items through the notice and comment 
rulemaking process in order to reduce the risk of fraud, waste, and 
abuse.

II. Provisions of the Notice

    In the CY 2013 Physician Fee Schedule final rule with comment 
period (77 FR 69154), we stated that we would publish annually an 
updated List of Specified Covered Items. (See also 42 CFR 
410.38(g)(2).) We specified that we would--(1) Add to the list any item 
of DME (described by an HCPCS code) that in the future appears on the 
DMEPOS Fee Schedule with a price ceiling at or greater than $1,000; and 
(2) remove from the list any item of DME with a HCPCS code that is no 
longer covered by Medicare or that has been discontinued.
    The purpose of this notice is to provide the annual update to the 
DME List of Specified Covered Items as stated in the CY 2013 Physician 
Fee Schedule final rule (77 FR 69154) and as specified in our 
regulations at Sec.  410.38(g).
    This year's update does not reflect any additions because there are 
no new items that appear on the DMEPOS Fee Schedule with a price 
ceiling at or greater than $1,000. There are also no new HCPCS codes 
for any of the five types of durable medical equipment listed 
previously. However, the following two HCPCS codes were removed from 
the list because they are for items that are no longer payable by 
Medicare:

------------------------------------------------------------------------
               HCPCS code                        Short descriptor
------------------------------------------------------------------------
E0457..................................  Chest shell.
E0459..................................  Chest wrap.
------------------------------------------------------------------------

    The full updated list is available in the download section of the 
following CMS Web site: http://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment.html.

III. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

IV. Impact Statement

    We have examined the impact of this notice as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
The CY 2013 expenditures for the two HCPCS codes being removed via this 
notice was approximately $9,000. Therefore, this notice does not reach 
the economic threshold and thus is not considered a major rule.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
less than $7.5 million to $38.5 million in any 1 year. Individuals and 
States are not included in the definition of a small entity. We are not 
preparing an analysis for the RFA because we have

[[Page 16414]]

determined, and the Secretary certifies, that this notice will not have 
a significant economic impact on a substantial number of small 
entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area for Medicare payment regulations and has fewer than 
100 beds. We are not preparing an analysis for section 1102(b) of the 
Act because we have determined, and the Secretary certifies, that this 
notice will not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2014, that 
threshold is approximately $141 million. This notice will have no 
consequential effect on State, local, or tribal governments or on the 
private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. Since this notice does not impose any costs on State or 
local governments, the requirements of Executive Order 13132 are not 
applicable.
    In accordance with the provisions of Executive Order 12866, this 
notice was reviewed by the Office of Management and Budget.

    Dated: March 10, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-07108 Filed 3-26-15; 8:45 am]
 BILLING CODE 4120-01-P

16414 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices

determined, and the Secretary certifies, DEPARTMENT OF HOMELAND are part of the National Customs
that this notice will not have a SECURITY Automation Program (NCAP). NCAP
significant economic impact on a was established in Subtitle B of Title
substantial number of small entities. U.S. Customs and Border Protection VI—Customs Modernization, in the
In addition, section 1102(b) of the Act North American Free Trade Agreement
Modification of National Customs Implementation Act (Pub. L. 103–182,
requires us to prepare a regulatory Automation Program (NCAP) Test 107 Stat. 2057, 2170, December 8, 1993)
impact analysis if a rule may have a Concerning Automated Commercial (Customs Modernization Act). See 19
significant impact on the operations of Environment (ACE) Cargo Release for U.S.C. 1411. Through NCAP, the initial
a substantial number of small rural Type 03 Entries and for Truck Carriers focus of customs modernization was on
hospitals. This analysis must conform to trade compliance and the development
AGENCY: U.S. Customs and Border
the provisions of section 604 of the Protection, Department of Homeland of the Automated Commercial
RFA. For purposes of section 1102(b) of Security. Environment (ACE), the planned
the Act, we define a small rural hospital successor to the legacy Customs
ACTION: General notice.
as a hospital that is located outside of Automated Commercial System (ACS).
a Metropolitan Statistical Area for SUMMARY: This document announces ACE is an automated and electronic
Medicare payment regulations and has U.S. Customs and Border Protection’s system for commercial trade processing.
fewer than 100 beds. We are not (CBP’s) plan to modify the National ACE will streamline business processes,
preparing an analysis for section 1102(b) Customs Automation Program (NCAP) facilitate growth in trade, ensure cargo
of the Act because we have determined, test concerning Automated Commercial security, and foster participation in
and the Secretary certifies, that this Environment (ACE) cargo release to global commerce, while ensuring
notice will not have a significant impact allow importers and customs brokers to compliance with U.S. laws and
on the operations of a substantial file type 03 entries for all modes of regulations and reducing costs for CBP
number of small rural hospitals. transportation and to file, for cargo and all its communities of interest. The
transported in the truck mode, entries ability to meet these objectives depends
Section 202 of the Unfunded for split shipments or partial shipments upon successfully modernizing CBP’s
Mandates Reform Act of 1995 also and entry on cargo which has been business functions and the information
requires that agencies assess anticipated moved in-bond from the first U.S. port technology that supports those
costs and benefits before issuing any of unlading. functions. CBP’s modernization efforts
rule whose mandates require spending DATES: The ACE Cargo Release Test are accomplished through phased
in any 1 year of $100 million in 1995 modifications became effective on releases of ACE component
dollars, updated annually for inflation. March 1, 2015. The ACE Cargo Release functionality, designed to introduce a
In 2014, that threshold is approximately Test will continue until CBP publishes new capability or to replace a specific
$141 million. This notice will have no in the Federal Register an legacy ACS function. Each release will
consequential effect on State, local, or announcement of its conclusion. begin with a test, and will end with
tribal governments or on the private ADDRESSES: Comments or questions mandatory compliance with the new
sector. concerning this notice and indication of ACE feature, thus retiring the legacy
Executive Order 13132 establishes interest in participation in ACE Cargo ACS function. Each release builds on
certain requirements that an agency Release Test should be submitted, via previous releases, and sets the
must meet when it promulgates a email, to Steven Zaccaro at foundation for subsequent releases.
steven.j.zaccaro@cbp.dhs.gov. In the The ACE Cargo Release test was
proposed rule (and subsequent final
subject line of your email, please use, previously known as the Simplified
rule) that imposes substantial direct
‘‘Comment on ACE Cargo Release 03 Entry Test, because the test simplified
requirement costs on State and local Entries and Truck Mode.’’ The body of
governments, preempts State law, or the entry process by reducing the
the email should identify the ports number of data elements required to
otherwise has Federalism implications. where filings are likely to occur.
Since this notice does not impose any obtain release for cargo transported by
FOR FURTHER INFORMATION CONTACT: For air. The original test notice required
costs on State or local governments, the policy questions related to ACE, contact
requirements of Executive Order 13132 participants to be a member of the
Josephine Baiamonte, Acting Director, Customs-Trade Partnership Against
are not applicable. Business Transformation, ACE Business Terrorism (C–TPAT) program. Through
In accordance with the provisions of Office, Office of International Trade, at phased releases of ACE component
Executive Order 12866, this notice was josephine.baiamonte@dhs.gov. For functionality, this test has been
reviewed by the Office of Management policy questions related to ISF, contact expanded to allow all eligible
and Budget. Craig Clark, Program Manager, Cargo participants to join the test for an
and Conveyance Security, Office of indefinite period regardless of the
Dated: March 10, 2015. Field Operations, at craig.clark@ C–TPAT status of an importer self-filer
Andrew M. Slavitt, cbp.dhs.gov. For technical questions, or a customs broker. CBP also expanded
Acting Administrator, Centers for Medicare contact Steven Zaccaro, Client the ACE Cargo release test to allow ACE-
& Medicaid Services. Representative Branch, ACE Business participating brokers and importers to
[FR Doc. 2015–07108 Filed 3–26–15; 8:45 am] Office, Office of International Trade, at file for release of cargo transported by
steven.j.zaccaro@cbp.dhs.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES

BILLING CODE 4120–01–P air, ocean, or rail. See 79 FR 6210
SUPPLEMENTARY INFORMATION: (February 3, 2014). For these three
Background modes of transportation, CBP limited
the ACE Cargo Release test to formal
I. The National Customs Automation consumption entries, which ACS
Program termed Type 01 entries; and to informal
This test notice, and the Customs entries, which ACS termed Type 11
related electronic functions it describes, entries. See 79 FR 6210.

VerDate Sep<11>2014 20:59 Mar 26, 2015 Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\27MRN1.SGM 27MRN1

Document Created: 2015-12-18 11:36:07
Document Modified: 2015-12-18 11:36:07

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		March 27, 2015.
Contact		Charlene Harven (410) 786-8228.
FR Citation		80 FR 16413

80 FR 16413 - Medicare Program; Updates to the List of Durable Medical Equipment (DME) Specified Covered Items That Require a Face-to-Face Encounter and a Written Order Prior to Delivery

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 59 (March 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services